BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 4439400 · Received January 21, 2015

    Report

    Report Number
    2015691-2015-00140
    Event Type
    Malfunction
    Date Received
    January 21, 2015
    Date of Event
    December 9, 2014
    Report Date
    December 22, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL# 6625-LP, PMA# P870077. METHOD: DEVICE REMAINS IMPLANTED. ADDITIONAL MANUFACTURER NARRATIVE THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS AS THIS REMAINS IMPLANTED IN THE PATIENT. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS EVENT, OR CONFIRM THE CLINICAL OBSERVATION. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED WHICH INDICATES THE PATIENT HAS UNDERGONE INTERVENTION FOR THE FAILING SURGICAL VALVE. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED ADDITIONAL INFORMATION THAT THIS FAILING SURGICAL MITRAL VALVE UNDERWENT INTERVENTION WITH PLACEMENT OF A TRANSCATHETER VALVE (VALVE-IN-VALVE).

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS SURGICAL MITRAL VALVE IS FAILING DUE TO MITRAL REGURGITATION CAUSED BY STRUCTURAL VALVE DEGENERATION. THE IMPLANT DURATION OF THE SURGICAL VALVE IS APPROXIMATELY ELEVEN (11) YEARS. AS REPORTED, INTERVENTION HAS YET TO TAKE PLACE; HOWEVER, THE PATIENT IS SCHEDULED TO UNDERGO VALVE-IN-VALVE INTERVENTION. NO ADDITIONAL DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50185 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R